Adipose Tissue Function After Pancreas Transplantation
- Conditions
- Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1End Stage Renal Disease
- Interventions
- Procedure: Adipose tissue biopsy
- Registration Number
- NCT01729130
- Brief Summary
Clinical measures of adipose tissue mass (BMI, waist circumference, waist-to-hip ratio) do not adequately explain the inter-individual and ethnic heterogeneity in diabetes. . There is a need to identify novel/universal markers of risk for diabetes (DM) and cardiovascular disease (CVD). These biomarkers also can become additional outcome measures for an intervention such as pancreatic/kidney transplant. If biological markers show an improvement with an intervention before anthropometric changes occur, intermediate outcomes can be an encouraging finding for practitioners. This study will focus on the central question of "adipose tissue dysfunction" as mediator of metabolic complications of positive energy balance, independent of body fat content and distribution. This study will address the question of effect of hyperglycemia on adipose tissue function independent of body fat mass. This project will take advantage of unique expertise of our investigators to perform detailed metabolic studies in patients with diabetes who undergo pancreatic/kidney transplant. The results of the proposed study will provide support to the novel approach of identifying adipose tissue dysfunction, rather than obesity and fat distribution, as predictor of diabetes and CVD across all ethnic groups, age and gender. We will obtain necessary preliminary data for future grant submissions to support our central hypothesis and develop stronger interactions within and outside The University of Texas Medical Branch (UTMB) with clinical investigators in the area of DM and its complications.
- Detailed Description
detailed description is his protocol
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- Men and women of any ethnicity, and age between 18 and 65 years.
- Patients with diabetes and renal failure who have been scheduled kidney-pancreas or isolated kidney transplantation.
- Ability to speak read and understand English or Spanish
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Any evidence of acute or severe cardiopulmonary, thyroid, neurological disorders, as assessed by history and physical examination and laboratory testing.
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Any personal history of substance abuse (reported only).
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Alcohol intake above 7 grams/day.
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Pregnancy or lactation.
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Inability to give consent for this study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 2 DM with kidney transplant Adipose tissue biopsy Group 2 are patient with DM and ESRD and who will receive only a kidney transplant. Group 1 Pancreas/kidney transplant Adipose tissue biopsy Group 1 of patients with End Stage Renal Disease (ESRD) and Diabetes Mellitis who will receive a pancreas and kidney transplant. An adipose tissue biopsy and blood samples are collected at time of transplant surgery. A repeat adipose tissue needle biopsy and blood samples are collected between 3-12 months post transplant. Group 3 No DM and kidney transplant Adipose tissue biopsy Group 3 will be patients who do not have DM but do have the diagnosis of ESRD and will receive only a kidney transplant.
- Primary Outcome Measures
Name Time Method Change in body fat distribution 1 year post transplantation skinfold thickness changes from baseline to within 1 year post transplantation using tape measure, scale and calipers
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The University of Texas Medical Branch (UTMB)
🇺🇸Galveston, Texas, United States